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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01384487
Other study ID # Nidek RS3000-1
Secondary ID
Status Completed
Phase N/A
First received June 27, 2011
Last updated February 17, 2012
Start date June 2011
Est. completion date November 2011

Study information

Verified date February 2012
Source Nidek Co. LTD.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to evaluate any adverse events found during the clinical study.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed.

2. Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.

3. Subjects who sign an informed consent form to participate in the clinical study.

4. Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition.

Exclusion Criteria:

1. Diabetes mellitus (DM) and/or diabetic retinopathy

2. Hypertension (HT)

3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision

4. Cardiac, hepatic, renal and hematologic diseases

5. Current systemic administration of steroid

6. History of anticancer agent etc.

7. Optically-stimulated epileptic seizure

8. Dementia

9. Subjects who have other life threatening and debilitating systemic diseases

NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
United States Hamilton Glaucoma Center La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Retinal Thickness One Visit No
Primary Inner Retinal Thickness One Visit No
Primary Outer Retinal Thickness One Visit No
Primary RNFL Thickness One Visit No
Primary Optic Disc Analysis One Visit No
Primary G Chart One Visit No
Primary Anterior Chamber Angle Image One Visit No
Primary SLO Image One Visit No
Primary Pachymetry One Visit No
Secondary Any adverse events One Visit Yes
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